MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for RECLAIM DEEP BRAIN STIMULATOR (DBS) 3391 manufactured by Medtronic, Inc..
[22398824]
Subject's husband reported on (b)(6) 2015 that subject was suffering from the shingles. A preexisting medical condition that also occurred two years ago. Subject's left eye area was blistering, she was incoherent, unable to construct a sentence, and numbing. She was administered an iv of valacyclovir, and then prescribed 3 pills a day of valacyclovir hydrochloride, 1 gm. On (b)(6) 2015, subject's husband reported that she was hospitalized due to some kidney problems and thought that it was because of the shingles medication she was given. Subject was followed up later that day where she was reported to be doing better and more alert, producing urine, no pain complaint, no seizures, on iv. Subject was followed up again on (b)(6) 2015 and was reported to be discharged on (b)(6) 2015. When discharged, subject blood levels were back to normal, and behavior was back to baseline.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | MW5045121 |
| MDR Report Key | 4974725 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-31 |
| Date of Event | 2015-07-16 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-08-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RECLAIM DEEP BRAIN STIMULATOR (DBS) |
| Generic Name | DBS LEAD |
| Product Code | GYZ |
| Date Received | 2015-07-31 |
| Model Number | 3391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Hospitalization | 2015-07-31 |